Indietro

Which substances have to be notified to the Classification and Labelling Inventory?

The following substances will have to be notified to the C&L Inventory, irrespective of their quantities:

Substances which are subject to registration under REACH (= 1 tonne/year) and placed on the market. This includes substances on their own, substances contained in mixtures and certain substances contained in articles where REACH Article 7 provides for their registration. Notification of these substances is not necessary where a manufacturer, importer or Only Representative (OR) has already registered the substance with the classification and labelling according to CLP when its notification in line with CLP Article 40(1) is due. In particular, notification is not required of the importers covered by a registration that has already been done by an OR on their behalf. However, importers will have to notify a substance within one month of its placing on the market where the OR has not yet submitted the registration.

Substances classified as hazardous under CLP and placed on the market irrespective of tonnage. This includes substances which are classified as hazardous under CLP, but which are exempted from registration, e.g. polymers referred to in REACH Article 6(3); and

Substances classified as hazardous under CLP and present in a mixture above the concentration limits specified in Annex I of CLP or as specified in Directive 1999/45/EC, where relevant, which results in the classification of the mixture as hazardous, and where the mixture is placed on the market.

According to CLP Article 40, only manufacturers of substances and importers of substances or mixtures have the obligation to notify. Therefore, it is only the importer who has to notify a substance contained in a mixture to the Inventory, where the substance is hazardous or subject to registration.

Modified Date: 04/06/2015

ID: 0195

Version: 1.0

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Would only substances manufactured or imported in quantities of 1 tonne or more per year be subject to notification?

No, according to Article 39(b) of the CLP Regulation, the requirement for notification to the Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a mixture above legally defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words: the requirement for notification goes beyond substances manufactured or imported in quantities of 1 tonne or more per year.

Modified Date: 04/06/2015

ID: 0196

Version: 1.0

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Is it necessary to notify a non-hazardous substance that is also registered under REACH to the Inventory?

Yes, it is. Article 39(a) of CLP states that "substances subject to registration in accordance with Regulation (EC) No 1907/2006" fall within the scope of the C&L Inventory when they are placed on the market. Therefore, this applies to substances subject to registration under REACH and placed on the market, regardless of whether they are hazardous or not. Where a substance is not classified, the "not classified" option should be selected in Bulk XML file or in IUCLID 5 dossier, or in REACH-IT C&L on-line wizard when notifying it to the Inventory.

However, if the substance is not subject to registration and does not meet the criteria for classification as hazardous there is no notification obligation. It is noted that where a substance has not yet been registered, the notifier should notify according to the provision of CLP Article 40(3) since notification is independent from the registration deadlines (see also FAQ ID=209). Note also that if a company has already submitted a registration dossier for the substance including the classification and labelling according to CLP, the same company does not have to submit a separate notification to the C&L Inventory.

Modified Date: 04/06/2015

ID: 0197

Version: 1.0

This answer has been agreed with national helpdesks.

What is the deadline for notification to the Classification and Labelling Inventory?

After 1 December 2010, the deadline for notification to the inventory is one month after a substance has been placed on the market.

The one month period has to be calculated from the date a substance is placed on the market after 1 December 2010. This also applies to substances which had been placed on the market before 1 December 2010, but which were not placed on the market on 1 December 2010 itself, but only again afterwards.

For example, you as manufacturer or importer place a substance on the market on 8 November 2010, then you stop doing so for a while, and then you place it on the market again on 1 February 2011. You will then have to calculate the obligatory one month notification deadline from 1 February 2011, and therefore your notification is due on 1 March 2011.

Modified Date: 05/01/2017

ID: 0198

Version: 1.0

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Do I have to notify substances that are classified for a physical hazard and contained in a hazardous mixture?

Yes, you do. CLP Article 39(b) refers to all hazards. This includes notification of a substance classified for a particular physical hazard and contained in a mixture whenever the mixture is placed on the market and needs to be classified for a physical hazard due to the presence of that substance. It should be noted that the physical hazard class to which the mixture belongs could be different from that of the substance(s) causing the hazard. Expert judgment should be sought in case of doubt.

Modified Date: 04/06/2015

ID: 0200

Version: 1.0

This answer has been agreed with national helpdesks.

CLP refers in its Article 40(1) to a "group of manufacturers or importers". Is this the same as a SIEF?

No, it is not. The term "group" is not defined under the CLP Regulation, in particular it does not equate to a Substance Information Exchange Forum as defined under REACH. Nevertheless, SIEF members can decide to notify to the C&L Inventory as a group. In this case the identity of each member should be specified in the notification.

Modified Date: 04/06/2015

ID: 0202

Version: 1.0

This answer has been agreed with national helpdesks.

How should a group of manufacturers/importers for the purpose of notification to the Classification and Labelling Inventory be set up?

ECHA's REACH-IT system will offer the possibility of signing up as a group of manufacturers or importers (hereinafter referred to as "M/I Group"), in accordance with CLP Article 40(1). The concept "Group of MI" is not further defined in the CLP. Such a group can, for example, be a corporate company with different legal entities or a SIEF. It is nevertheless important that the members of a M/I Group are all manufacturers or Importers. Further guidance can be found in the REACH-IT Industry User Manual Part 15 – Manage your Group of Manufacturers or Importers available at:http://www.echa.europa.eu/support/dossier-submission-tools/reach-it/data-submission-industry-user-manuals

When a M/I Group notification is made in REACH-IT, the identity of each member should be specified in the notification. If the membership of the M/I Group is updated by adding a new member, then the new member will automatically be considered as having submitted the notification(s). It is noted that updating a notification made by a M/I Group is possible only by the group leader who has carried out the M/I Group notification. The group leader shall be careful to mention that he is submitting on behalf of the M/I Group every time he is updating the notification (otherwise the updated notification will be considered as having been made on behalf of the group leader only).

It is stressed that if the group leader who has carried out the M/I Group notification submits a registration dossier for the same substance without the M/I Group, the group is removed from the notification and the other group members are obliged to notify again. For this reason it is recommended that at least one of the group members creates his own REACH-IT account, even if this is not necessary for the group notification itself. If the group members also have their own REACH-IT account, the group leader can make a legal entity transfer to another member of the group before he submits his registration. A legal entity transfer warrants that the group notification is retained in the REACH-IT.

Modified Date: 04/06/2015

ID: 0203

Version: 1.0

This answer has been agreed with national helpdesks.

The term "notification" has been used in various contexts in the EU chemicals legislation. What is the difference between a notification under Directive 67/548/EEC, a notification under REACH, and a notification under CLP?

Under Directive 67/548/EEC, notification was related to new substances. The notification process referred to was the submission of a dossier containing relevant information on a new substance (i.e. a substance placed on the market in the EU after 18 September 1981) to the competent authority of a Member State. The amount of information required depended on the quantity in which the substance was placed on the market. The notification requirement for new substances under Directive 67/548/EEC was replaced by the registration requirement under REACH after its entry into force.

The use of the term "notification" under REACH refers to three different obligations:

the obligation to provide basic information to the Agency on substances in articles, under Article 7(2).

the obligation to provide basic information to the Agency on those substances that are exempted from registration for five years because they are manufactured or imported for the purpose of product- and process-orientated research and development, under Article 9(2).

the obligation for downstream users to inform the Agency when using a substance that is on the Authorisation List (Annex XIV to REACH) based on an authorisation granted to an applicant up their supply chain, under Article 66(1).

Finally, "notification" under CLP relates to the C&L Inventory established by the Agency. Manufacturers and importers are required to submit information on the classification and labelling of substances placed on the market to the Inventory, regardless of their quantities, in accordance with CLP Article 40. The Inventory is a database that was originally introduced by the REACH Regulation; it did not exist under the previous legislation.

Modified Date: 20/09/2016

ID: 0204

Version: 2.0

This answer has been agreed with national helpdesks.

Who must notify to the Classification and Labelling Inventory?

Both manufacturers who place a hazardous substance on the market and importers of a hazardous substance will have to notify the classification and labelling of the substance to ECHA. This applies to substances on their own or contained in a hazardous mixture above a relevant concentration limit, which results in the classification of the mixture as hazardous, and irrespective of the quantity placed on the market. The obligation to notify will also apply to manufacturers and importers placing on the market a substance that is subject to registration under REACH, regardless of the classification. A separate notification is not required where the same information (i.e. the classification in accordance with the CLP criteria) has already been submitted as part of a registration under REACH by the same manufacturer or importer. If the registration dossier does not contain that information, it needs to be updated with the CLP information without undue delay. Notification can also be done by a group of manufacturers or importers.

Modified Date: 04/06/2015

ID: 0205

Version: 1.0

This answer has been agreed with national helpdesks.

Who is not expected to notify to the Classification and Labelling Inventory?

Downstream users, including formulators of mixtures, producers of articles as well as distributors of hazardous substances and mixtures do not need to notify to the C&L Inventory. This is because the notification of the respective substances should already have occurred at an earlier stage in the supply chain.

Importers of articles are also exempted from the obligation to notify the substances contained in imported articles in all cases where registration of these substances is not required, in accordance with REACH Article 7.

Natural or legal persons that manufacture substances, formulate mixtures or produce articles outside the EU cannot notify a substance to the C&L Inventory.

Only Representatives (OR) established under REACH only have a formal role when submitting the information which is needed for notification to the C&L Inventory as part of a registration dossier. The CLP Regulation does not foresee a formal role for an OR. However, it is accepted by ECHA that third parties are taking care of the submission of a notification on behalf of a group of manufacturers or importers which they represent. If such a solution is used, the submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification

Modified Date: 04/06/2015

ID: 0206

Version: 1.0

This answer has been agreed with national helpdesks.

Can Only Representatives who have been appointed under the REACH Regulation notify to the Classification and Labelling Inventory?

The CLP Regulation does not foresee a formal role for an OR. However, Only Representatives (OR) appointed under REACH may submit the information needed for notification to the Inventory as part of a REACH registration dossier. They may also submit separate notifications to the Inventory where they are notifying on behalf of a group of importers. Such a group notification should be done using REACH-IT. Contrary to the role of an OR under REACH, where such a solution is sought the importers will still remain responsible for the information notified to the Inventory. The submitting entity must be able to document that it has been mandated to act on behalf and in the name of the manufacturer(s)/importer(s) that are part of the group and that the manufacturer(s)/importer(s) acknowledge that they remain solely and fully responsible to fulfil all their obligations associated with the notification.

Modified Date: 04/06/2015

ID: 0207

Version: 1.0

This answer has been agreed with national helpdesks.

For substances with REACH registration deadlines in 2018, is it necessary to notify a substance to the C&L Inventory before the registration deadline?

What substance identity information is required for notification to the Classification and labelling Inventory?

The substance identity information required for notification to the C&L Inventory is set out in CLP Article 40 (1) (b); it includes the items listed in point 2.1 to 2.3.4 of Annex VI to REACH. In order to ensure proper identification of a substance, the provided information on substance identity should be consistent and unambiguous.

For example, in the case of a multi-constituent substance, the concentrations of its constituents should ideally add up to 100%. The identifiers provided by the notifier (i.e. IUPAC name, EC number, CAS name and CAS number) should also be consistent and they should refer to one substance.

For the purpose of notification of an imported substance either on its own or contained in a mixture, the importer should contact his non-EU supplier(s) to find out as much as possible about the identity of his substance.

Is analytical information such as HPLC data, gas chromatograms or a description of the analytical method required for notification to the Classification and labelling Inventory?

The following substance identity information is not required for the purposes of notifying to the C&L inventory: spectra, HPLC (high-pressure liquid chromatography) data, gas chromatograms nor a description of the analytical methods used for the identification of the substance and its possible impurities and additives. This is in contrast to the registration requirements under REACH where this information is required.

Modified Date: 04/06/2015

ID: 0212

Version: 1.0

This answer has been agreed with national helpdesks.

When notifying a substance to the Classification and Labelling Inventory, do its constituents, additives and impurities also have to be notified separately?

No, they do not. Constituents, additives and impurities of a substance do not need to be notified individually, even if they are hazardous and contribute to the classification of the substance. This is because they are included in the definition of a substance, pursuant to CLP Article 2(7): 'substance' means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. However, if these impurities, additives or constituents are also marketed as separate substances, these will of course have to be notified.

IUCLID 6 allows the indication of the presence of any impurities and additives necessary to preserve the stability of a substance as well as their contribution to a classification of the notified substance in section 1.2.

Modified Date: 05/01/2017

ID: 0213

Version: 1.0

This answer has been agreed with national helpdesks.

Can a company appear in more than one group of manufacturers/importers?

Yes, this is possible. A company may appear in more than one group of notifiers provided the substances being notified are different.

Modified Date: 04/06/2015

ID: 0214

Version: 1.0

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How should aqueous solutions of substances be notified according to Article 39 and 40 of CLP?

By definition, a solution composed of two or more substances is a mixture, see CLP Article 2(8) and REACH Article 3(2).

Therefore, substances contained in aqueous solutions should be notified to the C&L Inventory under the conditions of CLP Article 39(a) or (b) when they are placed on the market.

However, certain diluted acids and bases may be listed with the notation "%" in Annex VI to CLP. Such entries are treated as substances and should be notified as such to the C&L Inventory under the conditions of CLP Article 39(b) when they are placed on the market. In these cases, the harmonised entry as listed in Annex VI and any self-classifications for the hazard classes or differentiations not covered by this entry, if applicable, should be notified.

Modified Date: 04/06/2015

ID: 0215

Version: 1.0

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Does a manufacturer or importer have to notify substances listed in Annex VI of CLP?

Yes, he does; substances listed in Annex VI have to be notified in accordance with CLP Article 40 if placed on the EU market. Where a particular hazard class or differentiation is harmonised through Annex VI, this classification has to be used when notifying the substance. It is noted that for substances with a minimum classification in Annex VI, the notifier must classify in a more severe hazard category in cases where he has further information which shows that this is more appropriate (see also FAQ ID=260).

For non-harmonised hazard classes or differentiations of substances listed on Annex VI to CLP, the manufacturer or importer should self-classify the substance and introduce the resulting classification and labelling in his notification to the C&L Inventory according to Article 4(3) of CLP. In case he concludes that the substance should not be classified for these hazard classes or differentiations, the reason should be given in accordance with Article 40 (1) (d) of CLP.

Where a notifier proposes to apply a different non-harmonised classification and labelling for a substance than that which has already been submitted to the Inventory by another actor, the notifier has to provide a reason for his classification as part of his notification to the Inventory.

Modified Date: 04/06/2015

ID: 0216

Version: 1.0

This answer has been agreed with national helpdesks.

In relation to non-harmonised classifications, is it possible to notify a classification to the Inventory which differs from already existing entries on the Inventory for the same substance?

Yes, it is. On the C&L Inventory differing classifications for the same substance can have different reasons, e.g. different impurity profiles. In other cases, notifiers or registrants may have reached a different classification for the same substance due to interpretation differences in the process of evaluation of available data or in the application of the classification rules for CLP.

However, Article 41 of CLP requires notifiers and registrants to make every effort to come to an agreed entry for the same substance, unless a justification (e.g. impurity profile) can be provided for deviating classifications.

Modified Date: 04/06/2015

ID: 0217

Version: 1.0

This answer has been agreed with national helpdesks.

Once a substance has been notified to the C&L Inventory, will manufacturers or importers still have to notify the same substance although it is already on the Inventory?

Yes, they will. A notification must be made by each legal entity that places the substance on the market. Nevertheless, manufacturers or importers may prefer to notify as a group where only one notifier introduces the notification in REACH-IT on behalf of the other notifiers while introducing the identity of the latter as well.

In addition, if you are using the online REACH-IT tool for the submission of a notification and: a) the substance has already been notified by other manufacturer or importer and; b) you consider the displayed C&L for that substance appropriate, you can just tick the box "I agree" and the relevant fields of your notification dossier are automatically filled in.

Modified Date: 04/06/2015

ID: 0218

Version: 1.0

This answer has been agreed with national helpdesks.

Does the notifier have to give the reason for no classification according to CLP Art. 40 (1) (d) in cases where classification for an endpoint is excluded by definition?

Yes, he does. Notifiers, i.e. manufacturers and importers, will always have to provide a justification for "no classification". In line with the principles applied in the Submission Manual - How to prepare registration and PPORD dossiers, available on the ECHA web site at: https://echa.europa.eu/manuals

"The reason for no classification should be selected according to the following principles:

- "data lacking" should be selected if you do not have relevant data or other adequate and reliable information that can be compared with the classification criteria;

- "inconclusive" should be selected if you have data or other information but which is not reliable (e.g. data of poor quality) or if you have several equivocal study results or information. The available data/information cannot be regarded as a firm basis for classification;

- "conclusive although insufficient for classification" should be selected in cases where a substance is tested with the appropriate high quality study or where other high quality information is available.

It is also pointed out that there are certain 'classification waivers' in CLP:

- if a substance is classified for skin corrosion cat.1, it does not need to be classified for serious eye damage (but not vice versa),

- if a substance is classified for certain physical hazards, it does not need to be classified for certain others,

- if a substance has a particular physical state, e.g. it is a gas, it does not need to be classified as an oxidising solid or as corrosive to metals.

In case of such classification waivers you should select "conclusive, but not sufficient for classification" as a reason for no classification.

Note that one reason must be selected where a particular classification is not provided. It is up to the company to decide which reason to select. In case you do not fill in any reason for "no classification" in IUCLID 6, the dossier will fail the TCC (technical completeness check).

Modified Date: 05/01/2017

ID: 0219

Version: 1.0

This answer has been agreed with national helpdesks.

What is the difference between the labelling information required for a notification to the C&L Inventory under CLP and for a registration under REACH?

Pursuant to CLP Article 40(1)(f), a notification to the C&L Inventory should include the applicable CLP hazard pictograms, signal words and hazard statements as well as any supplemental hazard statements set out in sections 1.1 and 1.2 of Annex II of CLP or provided in Part 3 of Annex VI of CLP.

For a registration from 1 December 2010, the same CLP labelling elements as for a notification to the Inventory should be given. In addition, the registrant is requested to provide the relevant precautionary statements for a hazardous substance. When considering all identified uses covered in the registration dossier more than six precautionary statements may be necessary to reflect the nature and the severity of the hazards. This reflects the provisions of Section 4 of Annex VI to REACH as amended by CLP Article 58(11).

CLP Article 28(3) states that not more than six precautionary statements shall be given on the label, unless necessary to reflect the nature and the severity of the hazards. Since for many hazardous substances, the number of precautionary statements that can be assigned based on the classification of the substance will exceed the specified number of six statements, the manufacturer or importer will have to select them from those set out in the tables in Annex IV to CLP, in line with CLP Articles 22 and 28. The Agency is currently preparing guidance on the selection of precautionary statements for the CLP hazard label.

Modified Date: 04/06/2015

ID: 0220

Version: 1.0

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Does a notifier have to pay a fee when notifying to the Classification and Labelling Inventory?

No, he does not. The submission of a notification to the C&L Inventory is free of charge. Similarly, there are no fees for an update of the notification.

Modified Date: 04/06/2015

ID: 0221

Version: 1.0

This answer has been agreed with national helpdesks.

Would a company with subsidiaries in two Member States have to notify a substance twice, when it manufactures it in both Member States?

Yes, it would. As both subsidiaries are separate legal entities, each legal entity would have to notify the substance separately if in both cases it meets the criteria for notification in accordance with Articles 39(a) or (b) and 40(1) of CLP. Alternatively, both subsidiaries (as legal entities) may prefer to notify as a group of manufacturers (see also REACH FAQ ID=29).

Modified Date: 05/01/2017

ID: 0222

Version: 1.0

This answer has been agreed with national helpdesks.

Would only substances manufactured or imported in quantities of 1 tonne or more per year be subject to notification?

No, according to CLP Article 39(b), the requirement of notification to the C&L Inventory includes all hazardous substances within the scope of CLP, either on their own or contained in a hazardous mixture above defined concentration limits, and which are imported or manufactured and placed on the market within the EU. In other words, the requirement for notification applies irrespective of the tonnage manufactured or imported per year.

Modified Date: 04/06/2015

ID: 0223

Version: 1.0

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Is it required to update the C&L notification every time new information relevant for classification becomes available or are companies allowed to wait until they register the substance?

When preparing for the REACH registration of substances which have previously been only used for R&D purposes in amounts below 1 tonne per year used under strictly controlled conditions, potential registrants must collect available data, determine if relevant existing information is in line with Annex XI to the REACH Regulation and develop a testing programme. During this period there is a high likelihood that the classification of the substance will change.

Article 15(1) of the CLP Regulation obliges manufacturers, importers and downstream users to assess new information "without undue delay". Article 40(2) of the CLP Regulation further requires C&L notifiers to update their C&L notification "when, ---, a decision to change the classification has been taken".

ECHA recommends that the potential registrant carefully considers on a case-by-case basis when to update the C&L notification. Factors to be taken into consideration could, for instance, be additional time needed until the registration dossier is submitted, potential impact on the safe uses of the substance and practical consequences of revising the safety data sheet and labels. Companies should also keep all documentation available and consult the relevant authorities of their Member State.

Modified Date: 05/01/2017

ID: 0224

Version: 1.0

This answer has been agreed with national helpdesks.

Is it possible to flag confidentiality of certain information when notifying to the C&L Inventory?

Yes, it is. Manufacturers and importers can flag confidentiality of the IUPAC name when notifying certain substances to the Inventory. The substances for which confidentiality of the IUPAC name is possible are those listed in Articles 119(2)(f) and (g) of REACH, i.e.

- non-phase in substances,

- substances only used as one or more of the following:

- as intermediates,

- in scientific research and development,

- in product and process orientated research and development.

Where confidentiality of the IUPAC name is flagged when a substance is notified to the Inventory, the IUPAC name will not be displayed on the public part of the Inventory on ECHA's website. Where the IUPAC name has already been claimed confidential under a registration of the substance and ECHA has accepted the justification, the confidentiality claim will automatically be valid for the Inventory as well.

Modified Date: 04/06/2015

ID: 0226

Version: 1.0

This answer has been agreed with national helpdesks.

How do I flag confidentiality of the IUPAC name for an eligible substance when notifying it to the C&L Inventory?

To flag confidentiality of the IUPAC name in the C&L Inventory, a manufacturer or importer has to prepare a IUCLID dossier for notification of the substance to the Inventory. In that IUCLID dossier, he is requested to:

- set a confidentiality flag for the IUPAC name of the substance by ticking the appropriate box;

- attach a justification, including a clear indication whether the substance ranks among those referred to by REACH Article 119(2)(f) and (g), see FAQ ID=216, and

Notifiers are requested to provide all three elements for flagging confidentiality.

Nota bene: When notifying substance classifications to the C&L Inventory, notifiers must introduce the confidentiality flag through a IUCLID dossier. The other notification tools, i.e. the online and the bulk tool, do NOT include the possibility to flag confidentiality of the IUPAC name.

Modified Date: 05/01/2017

ID: 0227

Version: 1.0

This answer has been agreed with national helpdesks.

Is it necessary to pay a fee for flagging confidentiality?

No, it is not. Manufacturers and importers who flag confidentiality of the IUPAC name for a substance referred to by REACH Article 119(2)(f) and (g) do not have to pay a fee when notifying it to the Classification and Labelling Inventory.

Modified Date: 04/06/2015

ID: 0228

Version: 1.0

This answer has been agreed with national helpdesks.

What is the meaning of "placing on the market" in the context of CLP?

Placing a substance or mixture on the market under CLP means supplying or making the substance or mixture available to third parties, whether in return for payment or free of charge within the territory of the EU Member States and those EEA countries which have implemented the CLP Regulation.

In addition, import is deemed to be placing on the market and is defined as the physical introduction of a substance or mixture into the customs territory of the EU and those EEA countries which have implemented the CLP Regulation.

In relation to notification, placing on the market is a pre-condition. Substances which are referred to in CLP Article 39 have to be notified to the C&L Inventory if they are placed on the market. However, no notification is required if the information mentioned under CLP Article 40 has already been provided as part of a previous registration or notification by the same notifier.

The notification deadline is dependent on the date on which the substance is placed on the market. When a substance is placed on the market it must be notified to the C&L Inventory within one month.

In relation to import, the one-month timeline is counted from the day when the substance or mixture is physically introduced into the customs territory of the EU Member States and those EEA countries which have implemented the CLP Regulation.

Modified Date: 02/02/2016

ID: 0229

Version: 1.0

This answer has been agreed with national helpdesks.

Must a manufacturer or importer do physical hazard testing for classification purposes for substances not included in Annex VI to CLP or for substances included in Annex VI, but not classified for a specific physical hazard, and for which no adequate and reliable information is already available for the physical hazards?

According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 must be notified within one month after their placing on the market. In addition, CLP Article 4 (1) stipulates that the manufacturer or importer must classify their substances in accordance with Title II of CLP before placing them on the market.

Furthermore, CLP Article 8 (2) requires that for the purposes of determining whether a substance entails any of the physical hazards referred to in Part 2 of Annex I to CLP, the manufacturer or importer must perform the tests required in that Part, to allow classification of the substance, unless adequate and reliable information is already available.

Therefore, manufacturers and importers are required to perform physical hazard testing so as to classify their substances not included in Annex VI to CLP, or included but not classified for a specific physical hazard, and to notify this classification to ECHA within one month after their placing on the market.

However, substances may be placed on the market in very small quantities only (e.g. the quantity of a substance used in R&D (Research and Development)). These quantities may not be sufficient for the testing of physical hazards. When there is no adequate and reliable information already available on the physical hazards of these substances, it may not be feasible and/or proportionate for the manufacturer or importer to perform the tests required in Part 2 of Annex I to CLP. In those cases physical hazard testing should not be required. Nevertheless, every effort should be made to assess the physical hazards using any available theoretical methods e.g. UN test methods screening tests, along with expert judgment, and the most severe of the resulting classifications should be applied. Finally, as it is explained in FAQ ID=186 for R&D substances in particular, if neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required.

Modified Date: 05/01/2017

ID: 0230

Version: 1.1

This answer has been agreed with national helpdesks.

How do I notify to the C&L Inventory a specific form of a substance when there is already a harmonised C&L for the same substance in another form in Annex VI to CLP?

When a notifier is using the REACH-IT online tool to notify a substance already listed in Annex VI to the CLP Regulation, the C&L online functionality will automatically display the harmonised C&L without considering the potential form of the substance being notified.

Harmonised classification has to be respected and a notifier should not modify any of those harmonised hazard classes/differentiations. Nevertheless, in some cases, the classification of a substance has been harmonised only for a specific form (e.g. for zinc the harmonised entries refer to the powder or dust form and not to the massive form). In this situation, the substance may be self-classified in a specific form that is different from the form in Part 3 of Annex VI to CLP for some or all hazard classes or differentiations. The self-classification shall be based on the available data for that specific form.

Modified Date: 05/01/2017

ID: 0231

Version: 1.0

This answer has been agreed with national helpdesks.

Can the C&L notification number be used to identify a substance when searching the public C&L inventory?

No, a substance can only be identified by searching either with the CAS number, EC number or the substance identity. The C&L notification number can only be used by the notifier via REACH-IT.

Modified Date: 04/06/2015

ID: 0232

Version: 1.0

This answer has been agreed with national helpdesks.

Does the notification number received when a substance is notified to the Classification and Labelling Inventory need to be communicated through the supply chain (SDS, label, etc.)?

No, manufacturers or importers do not have the obligation to inform downstream users that they have submitted a notification to the C&L Inventory. Furthermore, there is no need for downstream users to receive confirmation from upstream suppliers that substances have been notified to the C&L Inventory in order to continue the use of the substances in their own products. Similar to the REACH pre-registration number, the C&L notification number is for internal use for the importer/manufacturer as receipt/proof of notification. It does not need to be communicated to the DU/distributor.

A notification number cannot be considered as an identifier according to Article 18 CLP and it is not the inventory reference number published in the C&L Inventory.

Modified Date: 04/06/2015

ID: 0233

Version: 1.0

This answer has been agreed with national helpdesks.

Are importers obliged to submit information on the impurities/additives of an imported substance in a mixture to fulfil the notification obligation under Article 40 (1) of CLP?

No, they are not. When a substance is present in a mixture, and the importer does not know whether it has been added as a substance as such or whether it is a constituent (additive/impurity) of a substance in the mixture, then that component must be notified if it meets the criteria in Article 39 of CLP. However, when the importer of a mixture has information that a substance present in the mixture is a constituent (additive/impurity) of another substance in the mixture, then the fields on impurities and additives can be filled in.